Objective To compare the effectiveness and safety of budesonide-glycopyrrolate-formoterol, a twice daily metered dose inhaler, and fluticasone-umeclidinium-vilanterol, a once daily dry powder inhaler, ...

Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, United States Food and Drug Administration (FDA), ...

which permits Teva to market and sell an inhaler device that administers the API albuterol sulfate. Teva listed several patents in the OB for ProAir® HFA, including several claiming components of ...

The medicine inside these rescue inhalers — the albuterol that quickly opens airways during an asthma attack — isn't changing. But the chemicals used to puff that drug into your lungs are. No more ...

[23] The Federal Circuit noted that “the fact that the FDA approved Teva’s ProAir® HFA combination product as a drug does not make the inhaler’s device parts a drug. They are still devices ...